FDA.reportPublic FDA data

BODY PRESCRIPTIONS Antibacterial Hand Wipes PINK GRAPEFRUIT

Manufacturer
ENCHANTE ACCESSORIES INC. | Zhejiang Ruolin Hygienic Products Co., Ltd.
Effective date
2020-06-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:17:23

Label at a glance#

ProductBODY PRESCRIPTIONS Antibacterial Hand Wipes PINK GRAPEFRUIT
Active ingredientBENZALKONIUM CHLORIDE
Label structure6 sections

Dosage and administration

For adults and children two years and over Peel over reusable label and remove a wipe from the packet. Wet hands thoroughly and air dry.  Place used wipes into waste basket.  Do not flush.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.1%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Use

INDICATIONS & USAGE SECTION

■ To decrease bacteria on hands

WARNINGS

WARNINGS SECTION

For external use only

Stop Use

OTC - STOP USE SECTION

Do not use if you are allergic to any ingredients listed

Discontinue use if irritation or redness occur. Consult a doctor if condition lasts for more than 72 hours

Do not get into eyes. Rinse thoroughly with water if contact occurs

keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

For adults and children two years and over

Peel over reusable label and remove a wipe from the packet.

Wet hands thoroughly and air dry. 

Place used wipes into waste basket.  Do not flush.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Ethylhexylglycerin, Citrus Grandis (Grapefruit) Fruit Extract, Phenoxyethanol, Propylene Glycol, Fragrance

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50563-218-012022-01-28C16284748780-1d6a99b39-dc2a-a426-e053-dadaa90af4c2G0ABCW03

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50563-218-01BODY PRESCRIPTIONS Antibacterial Hand Wipes PINK GRAPEFRUIT3 in 1 PACKAGESOLUTION31
50563-218-01BODY PRESCRIPTIONS Antibacterial Hand Wipes PINK GRAPEFRUIT20 in 1 PACKETSOLUTION201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50563-218BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES PINK GRAPEFRUIT (BENZALKONIUM CHLORIDE) SOLUTION [ENCHANTE ACCESSORIES INC.]1Legacy NDC, 2 package rows20200613_8c351869-6237-4d73-9a07-a922d96608b5.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50563-21850563-218-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GRAPEFRUIT JUICEJQ9EK2H6BGIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a7e98112-2207-8322-e053-2995a90a63778c351869-6237-4d73-9a07-a922d96608b52020-06-12WarningsExact identifier
spl id: a7e98112-2207-8322-e053-2995a90a6377
spl set id: 8c351869-6237-4d73-9a07-a922d96608b5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.